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Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for
instant download. All reference material as listed below and more is
available on a special seminar website. The website is regularly
updated with most recent information. In case there are questions
related to the topic, they can be submitted through a web form and
will be answered by the speaker. For ordering info
click here.

On-line Audio Seminar 175

Risk Based Computer Validation for Highest
Efficiency and FDA Compliance

Strategies and Tools for Implementation

Recorded

Recent FDA and industry guidances recommend to base the extent of validation of
software and computer systems on risk. This is great because when implemented
right it can help to reduce validation costs. Frequently risk categories are
easy to define but the real challenge comes when users should take action to
optimize risks versus costs. In this interactive audio seminar we will go
through various scenarios and recommend actions for validation and other
controls.

Key Questions are:

How to define how, medium and low risk systems

How to develop a risk based validation program

What to validate high, medium and low risk systems?

Should we do anything for low risk systems? (Recommendation
from FDA's John Murray at the IVT CSV conference: "Avoid the
words 'do nothing'. Define and implement controls for each
category".)

What to test for high/medium and low risk systems?

How to assess the supplier risk?

How to reduce testing through risk assessment?

How does business risk influence extent of validation?

How can I justify and document my decision?

How does the this audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new
interactive audio seminar. During the seminar, the speaker will
present strategies and give practical recommendations and examples.
After the seminar, an extensive list of reference material like
SOPs, templates and examples will help immediate and cost effective
implementation

About audio seminars

Online audio seminars are presented over the
phone. During the live presentation attendees can:

Study the printed slide material

Watch the slides on a computer

Watch the slides on a video screen in a seminar room

Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been
conducting over 300 web and audio or video based seminars since 15 years and and
he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world. This included seminars, workshops and presentations
for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
agencies.

Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from IVT's conference on Network Qualification
with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP® Special
interest group (SIG) on Laboratory Computers, PDA Part 11 task
force, IVT task force on network infrastructure qualification and
the European Compliance Academy. He frequently visited FDA in
Rockville, VA, and participated in panel discussions with FDA
professionals. For feedback from attendees of seminars and for
other information on Dr. Ludwig Huber,
click here.